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Piperacillin/Tazobactam Versus ceftriAxone and Metronidazole for Children With Perforated Appendicitis (ALPACA)

NCT05943223 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-07-13

No results posted yet for this study

Summary

This study is an internal pilot for a multicenter, blinded randomized controlled trial. The purpose of the multicenter trial is to determine whether post-operative piperacillin/tazobactam is more effective than ceftriaxone and metronidazole for children treated with laparoscopic appendectomy for perforated appendicitis. We plan to conduct an internal pilot study to determine whether a blinded multicenter randomized controlled trial is feasible.

Conditions

  • Appendicitis Perforated

Interventions

DRUG

Piperacillin/tazobactam

Post-operative piperacillin/tazobactam 100 mg/kg IV q8h (to a maximum of 4.5 g IV q8h)

DRUG

Normal saline

Post-operative normal saline 50 mL once daily

DRUG

CefTRIAXone Injection

Post-operative ceftriaxone 50 mg/kg IV once daily (to a maximum of 2 g IV once daily)

DRUG

Metronidazole Injection

Post-operative metronidazole 10 mg/kg IV q8h (to a maximum of 500 mg IV q8h)

Sponsors & Collaborators

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Michael H Livingston, MD, MSc · McMaster Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-09-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05943223 on ClinicalTrials.gov